Requirement of temperature data before dosing [Study Per­for­mance]

posted by anky1212 – India, 2017-07-20 08:08 (1117 d 16:29 ago) – Posting: # 17567
Views: 5,682

Hi All,

Please note following scenario,

Sponsor going to ship IP today but sponsor is not able to sent temperature data during shipment of product to CRO. Dispensing has been done without having temperature data during shipment. Tommorrow, there is dosing of subject.

Is it any concern for dispensing as well as dosing of subject even though temperature data during shipment not available?

Please provide your view on above scenario (along with guidance if available).

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